Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE

NCT02284178 | Completed Results DMC

• 1 other identifier: 1R01NR014508-01A1
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

Brief Summary

Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; aspiration; suctioning; secretions; ventilator-associated events

Outcome Measures

Primary Outcomes (2)

• Microaspiration as Measured by Tracheal Amylase

  Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.

  Every 12 hours up to 14 days

• Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant

  Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria

  Every 12 hours up to 14 days

Secondary Outcomes (2)

• Ventilator-Associated Condition (VAC) Rate

  VAC assessed for 2 days beyond last intervention; mean 5.4 days

• Time to VAC

  VAC was assessed for two days beyond the last intervention; mean 5.4 days

Other Outcomes (1)

• Tracheal to Oral Ratio of Amylase

  Every 12 hours up to 14 days

Study Arms (2)

Enhanced oral suction

EXPERIMENTAL

Deep oropharyngeal suction with catheter

Other: Enhanced oropharyngeal suction

Usual Care Oral Suction

SHAM COMPARATOR

Oropharyngeal suction with suction swab

Other: Usual Care

Interventions

Enhanced oropharyngeal suction OTHER

Deep oropharyngeal suction with catheter every 4 hours

Enhanced oral suction

Usual Care OTHER

Oral suction with suction swab every 4 hours

Usual Care Oral Suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• orally intubated with endotracheal tube and treated with mechanical ventilation
• hours or less since intubation
• expected to be intubated for at least 36 hours after enrollment

You may not qualify if:

• documented aspiration at time of intubation
• intubation to treat known aspiration
• treatment with rescue mechanical ventilation therapies (oscillator)
• re-intubation
• contraindications to receiving the intervention (e.g., oral injuries)
• history of lung or head/neck cancers that may produce amylase in the lungs
• history of disease that affects saliva production (e.g., Sjögren's syndrome)
• prisoners

Sponsors & Collaborators

• University of Central Florida: lead
• Orlando Regional Medical Center: collaborator

Study Sites (1)

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Related Publications (3)

• Bourgault AM, Xie R, Talbert S, Sole ML. Association of enteral feeding with microaspiration in critically ill adults. Appl Nurs Res. 2022 Oct;67:151611. doi: 10.1016/j.apnr.2022.151611. Epub 2022 Jun 30.

  PMID: 36116866 DERIVED

• Talbert S, Bourgault AM, Rathbun KP, Abomoelak B, Deb C, Mehta D, Sole ML. Pepsin A in Tracheal Secretions From Patients Receiving Mechanical Ventilation. Am J Crit Care. 2021 Nov 1;30(6):443-450. doi: 10.4037/ajcc2021528.

  PMID: 34719715 DERIVED

• Sole ML, Talbert S, Yan X, Penoyer D, Mehta D, Bennett M, Emery KP, Middleton A, Deaton L, Abomoelak B, Deb C. Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial. J Adv Nurs. 2019 Nov;75(11):3045-3057. doi: 10.1111/jan.14142. Epub 2019 Aug 7.

  PMID: 31241194 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Mary Lou Sole
• Organization: University of Central Florida

mary.sole@ucf.edu

407-823-5496

Study Officials

• Mary L Sole, PhD

  Univesity of Central Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 5, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 15, 2019
• Results First Posted: August 15, 2019

Record last verified: 2019-07

Locations

US (1)